AUDIENCE: Cardiology, Surgery, Risk Manager
ISSUE: The FDA is aware of recent reports regarding reduced leaflet motion in some bioprosthetic aortic valves, including both SAVR and TAVR devices. Importantly, most cases of reduced leaflet motion were discovered by advanced imaging studies in patients without symptoms of abnormal bioprosthetic valve function. Further, these studies have shown that in valves with reduced motion of one or more individual leaflets, there was acceptable forward blood flow through the valve opening without evidence of stenosis.
The definitive cause(s) of reduced leaflet motion in some bioprosthetic aortic valves also is not known. Evidence from imaging studies suggests that blood clot (thrombus) deposits on the leaflets may cause restricted motion. The prevalence of reduced leaflet motion was less in patients receiving therapeutic anticoagulation with warfarin compared with those receiving sub-therapeutic or no anticoagulation and with those receiving dual anti-platelet therapy.
In one study, treatment with blood thinning medications (anticoagulants) resulted in the resolution of the leaflet motion abnormalities.
At this time, FDA believes that bioprosthetic aortic valves remain reasonably safe and effective when used according to their approved indications. This view is supported by the favorable benefit/risk profile observed in SAVR devices in the 30 years they have been on the market and in TAVR devices in the 8 years they have been in use.
BACKGROUND: These reports have raised important questions about bioprosthetic aortic valves. However, limited available data do not allow FDA to fully characterize the causes, incidence, and short and long-term risks of reduced valve leaflet motion, or to recommend appropriate treatment. The FDA is working with the American College of Cardiology, the Society of Thoracic Surgeons, and the device manufacturers to design clinical studies to fully evaluate reduced valve leaflet motion for all types of bioprosthetic aortic valves.
RECOMMENDATION: For patients who have a bioprosthetic aortic valve, additional diagnostic imaging using 3D or 4D CT or TEE may be considered when clinically indicated. If reduced leaflet motion is found, treatment options should be discussed with the team of heart physicians responsible for the patient’s care.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with bioprosthetic aortic valves. If you suspect or experience a problem with a bioprosthetic aortic valve, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[10/05/2015 - FDA Notification]